Microneedling With Regular Insulin Versus Microneedling Alone in Treatment of Atrophic Scars

Scars Clinical Trial

Official title:

Microneedling With Regular Insulin Versus Microneedling Alone in Treatment of Atrophic Scars

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06021275
• Other study ID #: Scar 1
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: May 2024

Study information

• Verified date: January 2024
• Source: Alexandria University
• Contact: Dalia I Halwag, PhD, MD
• Phone: +00201224489473
• Email: daliahalwag[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Recently, few studies have attempted to test the regenerative effects of human insulin application by microneedling on atrophic scars versus other topical preparations. However, the scars were limited etiologically to acne scars. In addition, a lack of inclusion of a control group instead of comparing topical preparations with insulin was also a limitation to these studies. A control group consisting of microneedling alone would have served as a better comparison in order to determine whether the effects of microneedling are augmented by topical protein-rich preparations.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 60 Years

Eligibility

Inclusion Criteria:

1. Patients aged 12 to 60 years

2. Atrophic scars (traumatic or surgical)

3. Completely healed scars

Exclusion Criteria:

1. Patients with a tendency or history of hypertrophic or keloidal scars

2. Patients who received treatment for their scar in the past 3 months

3. Diabetic patients or those with a history of Dysglycemia

4. Pregnant, or lactating females

5. Patients with active infection at the site of scar

6. Patients currently receiving isotretinoin treatment or in the past month

Related Conditions & MeSH terms

• Atrophy
• Cicatrix
• Insulin
• Scars

Intervention

Other:
• Microneedling with topical application of regular insulin
Microneeling preformed onto the scar In one group insulin will be applied while saline will be used in the second group
• Microneedling with topical application of saline
Microneeling preformed onto the scar In one group insulin will be applied while saline will be used in the second group

Locations

Country	Name	City	State
Egypt	Alexandria University, Faculty of Medicine	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Scar	According the different scar assessment scores (e.g.POSAS score - The Patient and Observer Scar Assessment Scale score, range from 6 to 60, the higher the score the worse the scar, lowering in the score denotes improvement )	4 months